Committed timelines
Milestones agreed up front, along with what we need from your side to hit them. Then we stand by them.
Medical Device Design, Quality & Regulatory Readiness
Ready, by design.
Engineering, quality and regulatory support for medical devices, from the first design decision to approval, on timelines we commit to.
All device classesDiagnostic equipmentElectromechanical devicesSaMDSiMDLifecycle process automation
EU MDR · FDA 510(k) · CDSCOISO 13485 · 14971 · 10993Class I to III devicesNDA before any document
Services
Support at every stage of the lifecycle.
Open any area and add what you need. We'll bring your list to the first call, so it starts with your device, not a sales pitch.
Build your request
Add services from any area. Not sure what you need? Book a call and we'll scope it with you.
Why it matters
Find the gaps before the regulator does.
Most submissions don't fail at the regulator. They fail months earlier, in a gap nobody traced.
Earlier gap detection
Find design and documentation gaps before submission, not during it.
Less rework
Stronger traceability and evidence reduce costly late changes and repeat testing.
Confidence at submission
Go to the regulator with a complete, traceable and defensible file.
Free readiness check
How ready is your device?
Eight questions, about three minutes. Your score updates as you answer, and your answers stay on this page unless you choose to send them.
The score is weighted by the expected effort to prepare evidence. Weightings are Regzy’s assessment method, not percentages prescribed by regulators.
When classification is not confirmed, the assessment uses a conservative higher-risk weighting.
Select at least two target markets. Each market has its own classification system, so choose a class separately for each one.
How we work
From gap to go, in five steps.
One connected path from the first design decision to approval, so every decision made today still holds at submission.
Step 1
Assess
Review design, quality and regulatory evidence against your target markets.
Step 2
Prioritise
Rank every gap by patient risk and by its impact on your timeline.
Step 3
Remediate
Close gaps alongside your team with practical, right-sized fixes.
Step 4
Validate
Re-check that the evidence is complete, traceable and defensible.
Step 5
Submit
Prepare and support the submission, and the questions that follow it.
Regulatory readiness is not a document. It is a state of preparedness.
Why Regzy
What you can hold us to.
Transparent pricing
A clear, itemised proposal before any work starts. No hidden charges or surprise add-ons, and always open to discussion.
A team, not a freelancer
A dedicated lead plus specialists for every discipline your device needs, under one contract.
Global standard
Documentation built for EU notified bodies, the US FDA and CDSCO, at rates that make sense for growing manufacturers.
Three ways to start.
Most clients start here
Readiness assessment
A focused review of your current evidence against your target market's requirements.
- Prioritised gap report
- Remediation plan with effort estimates
- Read-out for your leadership
Defined deliverable
Project delivery
End-to-end ownership of one outcome, staffed with the specialists it needs.
- CE technical file or 510(k)
- DHF and traceability remediation
- ISO 13485 QMS build or audit readiness
Ongoing
Advisory support
A senior regulatory and quality function on call, for teams not ready to hire one.
- Monthly hours, planned around your roadmap
- Design reviews and change assessments
- Post-market and audit support
Team
Specialists across every discipline.
Every project has a dedicated lead as your single point of contact, backed by Regzy specialists who have done this work inside the companies you compete with.
Project leadership
A dedicated lead on every engagement.
Your Regzy lead owns the plan, the milestones and the quality of every deliverable, and is your single point of contact from the first call to submission.
Your team→Regzy leadone point of contact→Specialistsby discipline
SeniorMedTech expertise across disciplines
Class I-IIIdevices across EU, US, India
The team
Regzy specialists, by discipline.
Senior engineers, quality and regulatory professionals, each working in their own discipline. Specialists are assigned to the stages your device needs, work under NDA, and report to your project lead.
Design & systems engineeringRisk managementVerification & validationBiocompatibilitySterilisation & packagingElectrical safety & EMCSoftware, SiMD & SaMDCybersecurityUsability engineeringClinical evaluationQMS & auditsSubmissions
- One contract and one point of contact, however many specialists join.
- Your lead reviews every deliverable before it reaches you.
- You pay for the expertise each stage needs, not for a standing team.
Experience
Devices we know from the inside.
Hands-on EU MDR, US FDA 510(k) and CDSCO work across Class I, II and III devices.
Drug delivery
Pre-filled syringes, auto-injectors
Vascular access
Catheters, guidewires, IV sets, ISO 80369 connectors
Orthopaedic and surgical
Implants, surgical staplers
Ophthalmic
Intraocular lenses
Diagnostics and software
EEG and ECG electrodes, diagnostic equipment, SaMD and SiMD
Hospital equipment
Beds, carts, tourniquet cuffs, EVA bags
Client names and project details are confidential.
About
Partners, not a document factory.
Engineering excellence, quality and intelligent automation, in service of safe medical innovation reaching patients faster.
Our vision
To become the most trusted engineering and regulatory readiness partner for MedTech innovators, helping safe medical innovations reach patients faster through engineering excellence, quality and intelligent automation.
Our mission
We help medical device companies identify and eliminate design control, quality and regulatory gaps, for faster, more predictable submissions and less development risk.
Our belief
Compliance should enable innovation, with expert judgment at the centre of every decision.
Insights
Practical notes from the field.
Short guides on regulatory pathways, design controls and audits.
FAQ
Questions, answered.
Contact
Let's get your device ready.
Tell us where you are. We reply within one working day to set up a short call, with no obligation.